Ertapenem
These highlights do not include all the information needed to use Ertapenem for Injection safely and effectively. See full prescribing information for Ertapenem for Injection. ERTAPENEM for injection, for intravenous or intramuscular use Initial U.S. Approval: 2001
Approved
Approval ID
c4da28cb-6725-4fa1-a7b0-e84f408fb36b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
Savior Lifetec Corporation
DUNS: 658684423
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ertapenem Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44647-051
Application NumberANDA207647
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ertapenem Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (3)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ERTAPENEM SODIUMActive
Quantity: 1 g in 20 mL
Code: 2T90KE67L0
Classification: ACTIM